Adaptation and validation for Colombia of the WHO safe childbirth checklist

Abstract Introduction: Most maternal that deaths occur in developing countries are considered unfair and can be avoided. In 2008, The WHO proposed a checklist for delivery care, in order to assess whether a simple, low-cost intervention had an impact on maternal and neonatal mortality in low-income countries. Aim: To translate, adapt and validate the content of the WHO Safe Childbirth Checklist (SCC) for its use in Colombia Methods: The translation of the list was carried out, adaptation was made to our context and validation of content through a panel of experts composed of 17 health workers with experience in maternal and neonatal care and safety. The reliability among the judges was calculated (Rwg) and according to the results, items were modified or added to each section of the list. Results: Modifications were made to the wording of 28 items, none was eliminated, and 19 new items were added. The most important modifications were made to the management guidelines that accompany each item and the items included refer to risks inherent to our environment. Conclusion: The Colombian version of the SCC will be a useful tool to improve maternal and neonatal care and thereby will contribute to reducing maternal and neonatal morbidity and mortality in our country.


Introduction
Reducing maternal mortality is a public health priority worldwide and is one of the «Millennium Development Goals» of the United Nations 1 . According to figures from the World Health Organization (WHO), approximately 350,000 maternal deaths occur each year 2,3 ; most of these deaths occur in underdeveloped or developing countries, and most of them are considered unfair and can be avoided through timely interventions based on evidence 4,5 . In consequence, the Sustainable Development Agenda agreed as Goal 3.1 to reduce the global maternal mortality ratio (MMR) to less than 70 per 100,000 live births between 2016 and 2030 6 .
In Colombia, in 2014, the Ministry of Health and Social Protection estimated, based on DANE figures, an MMR of 53.7 per 100,000 live births; however, indicators by department show great inequities in the country, being the departments with higher poverty indexes those that have the highest maternal MMR, surpassing the national indicator even by three or four times 7 . Faced with this scenario, it is necessary to redouble efforts to achieve the commitments made, especially in the regions with the greatest inequities in terms of health in the country.
Interventions based on checklists have become more frequent in recent years to assist the management of complex or neglected tasks that are at risk of more mistakes. These are lists of items to be checked during a complex activity, as a memory aid, to ensure the correct execution of a task. Integration of checklist programs into clinical practice has shown to reduce mortality and the incidence of complications in surgery and intensive care [8][9][10][11] .
A strategy based on a checklist is well adapted to childbirth care if it considers several characteristics of the event, for example, that the main causes of maternal and perinatal mortality are well described; that most deaths occur within a short period of time (twenty-four hours after birth); that international guidelines for best practices exist but are not followed; and that some proven interventions are relatively inexpensive, cost-efficient, easy to implement, but may be difficult to remember and to implement in the appropriate sequence, which could be solved by using a checklist 12,13 .
For this reason, in 2008 the WHO established a safety program based on the Safe Childbirth Checklist to determine whether a simple, low-cost intervention had an impact on maternal and neonatal mortality in low-income countries. The initially proposed checklist contains 29 items addressing the leading global causes of maternal death (hemorrhage, infection, and hypertensive disorders); childbirth-related fetal death (inappropriate intrapartum care); and neonatal death (birth asphyxia, infection, and complications related to prematurity). It also addresses childbirth care (through both caesarean section and vaginal delivery), and simultaneously controls all preventable direct and indirect causes of maternal mortality within the first 24 hours after birth until discharge from hospital.
Pilot test results showed that the implementation of the childbirth checklist led to improved quality of care provided by health workers who attend institutional births 14 , in addition to being inexpensive, easy to carry out and with evidence of good results in 10 countries of Africa and Asia 5 .
Due to these results, in 2012, the WHO undertook an initiative that involved the collaboration of 29 countries and 34 research groups that mainly sought to evaluate the factors that facilitated or hindered the application and effective use of this instrument, leading to the design of an implementation guide and an updated checklist 15 . However, it has not yet been implemented in Colombia, and studies are needed to determine its applicability and acceptance in our context.
In order to use this instrument with a different population, its format should be modified to suit the context in which it will be used. Therefore, within the framework of the worldwide pilot study, the checklist had to be translated and adapted to our context. This study sought to translate, adapt and validate the content of the WHO Safe Childbirth Checklist for its use in Colombia.

Materials and Methods
Design Validation study of instruments.
Selection and description of participants A team of 17 experts in patient safety, obstetrics, maternal and neonatal safety and mortality were available for expert consensus: 6 anesthesiologists, 1 internist, 5 obstetrician-gynecologists, 4 nurses and 1 pediatrician neonatologist. Most of them had more than 10 years of experience, and only 2 had less than that (7 and 2 years); they were selected by expert referral. The list of expert judges can be seen in Annex 1.

Process
The indications of the American Psychological Association (A.P.A.) for the adaptation of measuring instruments were followed to adapt the instrument, which include: 1) making sure that there is equivalence between languages and cultural groups of interest, 2) deciding whether to adapt an existing instrument or prepare a new one, 3) selecting qualified professional translators, 4) performing direct or inverse translation, 5) reviewing the adapted version of the instrument and making the necessary corrections, among others 16,17 . With these recommendations in mind, this study followed the steps below: Phase 1. Translation The original instrument was translated by a qualified Colombian translator; this version was reviewed by the co-researchers of the project. The final adjustments to the translation were made in accordance with their suggestions and observations. Phase 2. Content validity The evaluation of the contents is usually performed by a panel of experts or expert judges, and is defined as «an informed opinion of people with experience in the subject, who are recognized by others as qualified experts, and who can provide information, evidence, judgments and assessments» 18 . In this study, content validity was analyzed by means of a consensus of evaluators applying the discussion and consensus methodology among the experts from a modified Delphi 19 .
The group of judges received a format to assess the clarity and relevance of each item in the checklist, as well as their sufficiency to measure each phase of childbirth care proposed in the original instrument. The scores given to each behavior or section, in each of these categories, ranged from 1 to 4 on a Likert scale, according to the criteria shown in Table 1.

Reliability between judges (
: within-group interrater reliability) was calculated for each behavior. This is used to determine the level of agreement among evaluators when validating the items, and is estimated by: to help health workers improve their practices in maternal and newborn care. It focuses on the leading causes of maternal mortality worldwide (hemorrhage, infection, hypertensive disorder and dysfunctional labor), intrapartum-related stillbirths (inadequate care) and neonatal deaths (events during labor, infections and preterm complications). Each item on the list is a critical action and its omission can lead to serious outcomes.
Pilot tests have shown that the SSC (version 1.0) has improved the practices of health workers 5 . Four sections (pause points) are proposed and a set of essential practices should be completed (list of items) during each pause. A checklist should be used for each mother and her baby, and each item should be checked by marking it when it has been completed or performed. Nurses, midwives, doctors, or other health care workers are responsible for filling out the form.
Pause points occur during critical situations when complications can be avoided or adequately managed. They also occur at times when it is convenient to check the mother and the newborn. Thus, the Safe Birth Checklist is designed to be used at these four pause points during institutional births: 1. On admission (8 items) 2. Just before pushing or before cesarean section (5 items) 3. Soon after birth within 1 hour (9 items) 4. And, before discharge (7 items) Ethical Considerations This work complies with national and international recommendations for biomedical research 22,23 . The research protocol was approved by the Ethics Committee of the Universidad Nacional de Colombia.

Bias Control
In order to control possible bias among members of the consensus, a modified Delphi was applied, for which the experts gave their scores individually and blinded to the scores of the other experts Table 1. Definition of each category and scores to be applied in the valuation of the items and sections of the list.

Clarity (Cla)
The item is easily understood, i.e. its syntax and semantics are appropriate 1. The item is not clear 2. The item requires several modifications or a very large modification regarding the use of the words according to their meaning or order. 3. A very specific modification of some of the terms of the item is required. 4. The item is clear and has appropriate semantics and syntax Relevance (Rel) The item you are reviewing is important for the application of the checklist as it relates to an important and necessary aspect that has to be checked during labor and should therefore be included in the instrument.
1. The item can be removed. 2. The item has some relevance, but another item may include what it measures. 3. The item is important but is not decisive enough to be included. 4. The item is very important, it should be included.

Sufficiency (Suff)
The items related to the same moment in the checklist are sufficient to cover the essential aspects that need to be verified during labor. 1. The items are not sufficient. 2. Items cover some part, but not all of it; items should be added or changed. 3. Few items should be added or changed in order to cover the essential aspects to be verified during labor. 4. The items are sufficient to obtain a complete measurement of the essential aspects to be verified during labor.

Where
indicates reliability between evaluators, in a group of k evaluators per item X j : S Xj 2 is the observed variance of X j and Xj y X j y σ EU 2 is the randomly expected variance of X j , that is, a condition of reliability between evaluators equal to zero 20 .
According to this calculation, it possible to decide if an item had to be removed, modified or not, and if new items had to be added or not to each phase of the list. The accepted criterion was that if the level of agreement (Rwg) did not exceed a cut-off point of 0.8, the item or instrument had to be modified 21 . In this case, Rwg less than 0.8 in clarity indicated the need to modify the item; Rwg less than 0.8 in relevance required discussing whether or not to remove the item; and Rwg less than 0.8 in sufficiency revealed that there were items that needed to be included in the version for Colombia. This process was carried out several times until the modifications made showed agreement among the judges above the cut-off point.

Instrument
The Safe Childbirth Checklist (SCC) was developed by the WHO along with nurses, midwives, obstetricians, pediatricians, patient safety experts and patients from around the world as a strategy first. Then each expert received a scoring device on the day of faceto-face consensus, so that each one gave again an individual score, blinded to the scores of the other experts.

Results
Once reliability among judges (Rwg) for each item and care phase was established, and taking into account the decision criteria, modifications were made to 28 items, in order to make them more suitable for use in our context. No items were removed, and 1 item remained the same; the results are presented in Figure 1 and Table 2.
As Table 2 shows, the most important modifications were made to the management guidelines that accompany each item and some minor modifications to the wording or the terms used in them.
Furthermore, 19 new items were added: 4 in the admission phase, 9 before delivery, 2 soon after birth and 4 in the discharge phase. The 4 items of the admission phase refer to allergy review, need for antihypertensive and syphilis treatment, while the supplies item was divided into two parts. The 9 items added to the section before birth are explained by the fact that the supplies item was considered as one, while it was separated in the new version; in addition questions about partogram and the need for antihypertensive treatment were added. In the section soon after birth, two items were added regarding the need for an antihypertensive medication for the mother and screening for congenital hypothyroidism and hemoclassification for the newborn. Finally, in the section before discharge, 4 items were added that refer to investigating if anemic syndrome is observed in the mother, if a postpartum control appointment was scheduled, if treatment for syphilis was given, and if catheters and foileys were used.
The final version of the Safe Birth Check List for use in Colombia can be seen in Annex 2

Discussion
The Safe Childbirth Checklist 5 , as its surgery counterpart 8 , is an instrument used to optimize standardized processes followed by health personnel, making sure that clinicians take into account events and actions that each stage of labor may require to provide care to patients with better quality. It is not a guide to clinical practice, yet it provides a minimum standard of care, favoring assessment during each birth and considering basic behaviors relevant to each patient, contributing significantly to clinical safety for the patient and legal security for the staff that provide care.
To incorporate these benefits to the maximum, the instrument requires to be adapted to the context in which it will be applied 14,15 , as exposed in this article.
Thus, following the methodology described above, after the translation of the original document and after reviewing and adjusting the Spanish version of each question and its recommendations, consensus points were modified and added to each of the four items on the list. For the first section, admission, all items were modified, adding considerations to each question, and formulating four new ones. Thus, regarding partogram, the suggested times for monitoring signs were modified. The proposal to take blood pressure every 2 hours instead of every 4 hours was considered because every 4 hours is a very long period of time to assess the impact of possible measures that may be taken. Measuring temperature every 4 hours rather than every 2 hours is explained by the fact that fever during labor is considered infrequent and that this parameter is not variable as to look for alterations so frequently. Controlling maternal and fetal heart rate every 30 minutes is also necessary, as well as measuring uterine activity every hour, since these parameters present a rapid variation based on the change of clinical conditions and the interventions in the patient and the neonate.   Arrange follow-up and confirm mother / companion will seek help if danger signs appear after discharge. 0.78 1.00 Modify Do

not remove
The mother or companion recognize warning signs and will seek help if: Mother: Bleeding, severe abdominal pain, severe headache, visual disturbance, shortness of breath, fever or chills, difficulty urinating.
Baby: difficulty breathing/fast breathing, fever, cold skin, weak sucking, drowsy or hard to wake up, yellowing of the eyes, skin, palms of hands, or soles of feet.
Regarding the use of antibiotics for the mother, modifications were made to several items on the list. On admission, antibiotic therapy was added in patients confirmed as carriers of S. Agalactiae 24 in whom there is suspicion of gestation of less than 37 weeks or with a rupture of membranes of 18 hours, because this infection very often leads to early neonatal sepsis, which in many cases leads to neonatal death. It is worth noting that, in case of clinical suspicion of an infection in the mother in any site, the corresponding antibiotic therapy should be initiated, since such infection could complicate labor with unfavorable outcomes for the mother and/ or the newborn. With respect to the use of magnesium sulphate, considerations for administration were extended, especially its use in case of eclampsia 25 .
New questions were also added. One is related to the presence of allergies in the mother, because it is essential to know, from the very beginning of childbirth care, whether the patient may present an allergic reaction that manifests itself as an anaphylactic shock that could lead to death. The second refers to whether the mother requires treatment for syphilis, considering the high prevalence of this disease in our context and the possibility of transmission to the fetus, thus protecting the mother and preventing congenital syphilis. Treatment for syphilis with antitreponemal antibiotic therapy is categorical and determinant if the mother is diagnosed with syphilis 26 . If the status of syphilis is unknown, the institutional protocol for syphilis test should be followed and treatment should be defined according to the results. The third question asks about whether the mother requires antihypertensive management, taking into account that gestational hypertension could cause maternal and fetal morbidity and mortality; this is a predisposing factor to the development of potentially fatal complications such as placental abruption, brain hemorrhage, hepatic and renal failure and disseminated intravascular coagulation 27 .
With respect to the second section, just before the expulsion or caesarean section, some questions were added. One refers to the initiation of antihypertensives and another to the evolution of the partogram, because answering these questions seeks to predict complications and the need for interventions at birth. Suspicion or infection by S. Agalactiae was added to the section that refers to antibiotic therapy for the mother, and the need to initiate antibiotic therapy if there is a suspicion of infection of any site. The indication for antibiotic therapy was removed when prolonged rupture of membranes occurs (more than 18 hrs) since this consideration should be made on admission; it has no place in this section either if the patient was admitted to the institution during expulsion, because it should be answered at both moments of the checklist, both in the admission section (where this indication is referred) and in the just before childbirth or cesarean section.
During the third section, after delivery or cesarean section (and up to one hour later), the mother is also asked whether she took magnesium sulphate during pregnancy, and the clinician is asked to consider the same indications as in the previous two sections. This part also refers to the use of antibiotic therapy, extending the indications of the original list by adding use of antibiotics for instrumental delivery, manual removal of the placenta, uterine revision, severe perineal tear and clinical suspicion of infection of any site. This section also includes the baby, considering indications of need of referral, antibiotic therapy and special monitoring, which were maintained. Modifications were made to the item antibiotic therapy, ruling out neonatal seizures at this stage as an indication for administering antibiotic therapy because this symptom, right at birth, is considered to be caused by clinical situations other than neonatal infection, such as hydroelectrolytic disorders, hypoglycemia and metabolic disorders. Antibiotic therapy for congenital syphilis and APGAR less than 7 (which predisposes to more infections in neonates) were added. A new question was added regarding screening for congenital hypothyroidism and blood sample collection for hemoclassification in the newborn, which should occur during labor, before expulsion, by collecting blood from the umbilical cord, to avoid unnecessary puncture in the baby and considering that the collection of the sample after one hour leads to false results 28 . It is important to establish if the baby has hypothyroidism, since this pathology must be treated since birth as it may cause alterations, including neurological development alterations.
Finally, the last section of the checklist, before discharging both the mother and the baby, situations in which antibiotics should be administered were also established. Antibiotic therapy should be given to every mother with temperature above or equal to 38°C and foul-smelling vaginal bleeding, which coincides with the original checklist; however, initiating antibiotic treatment when there are signs of infection in the surgical site, superficial and deep and a clinical suspicion of infection in any site was added.
As for the baby, the same indications established in the original checklist were maintained, because, at this point, the probability that neonatal seizures are generated by infection is very high.
Regarding maternal HIV infection, the need for follow-up due to infectious diseases was added for both the mother and the baby for long-term control. The moments in which the postpartum check-up appointment should be granted by the outpatient clinic were clarified, so an appointment at seven days is recommended if the delivery was low risk and at 48 hours if there were risk factors. Finally, questions of whether the mother and the baby received syphilis treatment, if the test was positive, and if probes and catheters were removed, were added; this seeks to avoid discharging the patient and her baby with possible infections or risk factors that may lead to an infection.

Conclusion
The Colombian version of the Safe Childbirth Checklist is expected to become an instrument useful to support institutions and improve care for mothers and newborns, while supporting the fulfillment of the objectives of sustainable development in our country. In addition, we expect that its implementation is especially useful in remote areas, where many safe practices are not systematically followed. All of this is intending to contribute to reducing maternal and neonatal morbidity and mortality.  Confirme la disponibilidad de suministros y el cumplimiento del protocolo para el lavado de manos.  Confirme la disponibilidad y uso de guantes para cada examen vaginal.